Idiopathic Inflammatory Myositis Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Idiopathic Pulmonary Fibrosis Pipeline Insight" report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Idiopathic Pulmonary Fibrosis pipeline landscape. It covers the Idiopathic Inflammatory Myositis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Idiopathic Inflammatory Myositis pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay ahead in the competitive pharmaceutical landscape with in-depth Pipeline Insights! Discover the latest advancements, key Idiopathic Inflammatory Myositis Companies driving innovation, and the most promising Emerging Drugs shaping the future of treatment. Download our comprehensive report now to explore clinical-stage developments and strategic collaborations transforming the industry! @ Idiopathic Inflammatory Myositis Pipeline Outlook Report [https://www.delveinsight.com/sample-request/idiopathic-pulmonary-fibrosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Key Takeaways from the Idiopathic Inflammatory Myositis Pipeline Report

* In February 2025:- Novartis Pharmaceuticals - A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
* In February 2025:- Janssen Research & Development LLC - The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
* In February 2025:- Cabaletta Bio - Idiopathic inflammatory myopathies (IIMs, or myositis) are a group of rare autoimmune diseases characterized by inflammation and muscle weakness. Though the cause of IIM is not well understood, some subtypes of IIM, including dermatomyositis (DM), anti-synthetase syndrome (ASyS), immune-mediated necrotizing myopathy (IMNM), and juvenile idiopathic inflammatory myopathy (JIIM), are thought to involve B cells that cause the body to attack different tissues in the body. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with DM, ASyS, IMNM, or JIIM who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.
* In February 2025:- Argenx:- The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
* In February 2025:- Pfizer - The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis [DM] or polymyositis [PM]). Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.
* DelveInsight's Idiopathic Inflammatory Myositis pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Idiopathic Inflammatory Myositis treatment.
* The leading Idiopathic Inflammatory Myositis Companies such as FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma Co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd., Ark Biosciences, Ocean Biomedical and others.
* Promising Idiopathic Inflammatory Myositis Therapies such as Daxdilimab, Belimumab, Baricitinib, Nipocalimab, Glucocorticoids, Froniglutide and others.

Uncover Idiopathic Inflammatory Myositis groundbreaking developments in the drug pipeline with our latest report! Gain exclusive insights into Idiopathic Inflammatory Myositis Clinical Trials, regulatory updates, and Emerging Drugs across multiple therapeutic areas. Learn how leading Idiopathic Inflammatory Myositis Companies are positioning themselves for success in the evolving pharmaceutical market-access the full report today!" @ Idiopathic Inflammatory Myositis Clinical Trials Assessment [https://www.delveinsight.com/sample-request/idiopathic-pulmonary-fibrosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Idiopathic Inflammatory Myositis Emerging Drugs Profile

* Pamrevlumab: FibroGen

Pamrevlumab is a proprietary therapeutic antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab represents a potential treatment for a broad array of fibrotic and proliferative disorders that affect organ systems throughout the body. Currently, the drug is in the Phase III stage of its development for the treatment of Idiopathic Pulmonary Fibrosis.

* Tipelukast: MediciNova

MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound which exerts its effects through several mechanisms to produce its anti-fibrotic and anti-inflammatory activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, histopathological data shows that MN-001 reduces fibrosis in multiple animal models. The US Food and Drug Administration (FDA) has granted orphan-drug designation to MN-001 (tipelukast) for treatment of idiopathic pulmonary fibrosis (IPF). Currently, the drug is in the Phase II stage of its development for the treatment of IPF.

* PLN-74809: Pliant Therapeutics

PLN-74809 is an oral small-molecule dual-selective inhibitor of v6 and v1 integrins for the treatment of IPF. While present at very low levels in healthy tissues, these integrins are upregulated in the lungs of IPF patients where they activate TGF-, a key driver of the fibrotic process. Blocking these integrins is designed to stop TGF- activation, potentially halting the growth of scar tissue. PLN-74809 has received Fast Track Designation and Orphan Drug Designation from the US Food and Drug Administration (FDA) in IPF and Orphan Drug Designation from the European Medicines Agency (EMA) in IPF. The company has completed enrollment in the Phase 2a clinical trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF) and announced positive data from the trial.

* HZN-825: Horizon Pharmaceuticals

HZN-825 is an oral selective LPAR1 antagonist that has shown early signs of clinical impact in systemic sclerosis. LPAR1 signaling has been implicated in fibrosis and inflammation, and preclinical and clinical evidence support the antifibrotic potential of LPAR1 antagonism across multiple organ systems, including both lung and skin. Currently, the drug is in the Phase II stage of its development for the treatment of Idiopathic Pulmonary Fibrosis.

* Brilaroxazine: Reviva Pharmaceuticals

Brilaroxazine, a novel serotonin-dopamine modulator with multifaceted activities has the potential to treat idiopathic pulmonary fibrosis (IPF). Serotonin (5-HT) signaling plays a key role, via 5-HT2A/2B/7 receptors, in the vasoactive effect on pulmonary arteries and lung myofibroblast actions. Brilaroxazine displays a high affinity and functional activity for the 5-HT2A/2B/7 receptors and moderate affinity for the serotonin transporter. Brilaroxazine's effects on vascular fibrosis (5-HT2B receptor), proliferation (5-H2A/2B receptor), relaxation (5-HT2A receptor), inflammation (5-HT7 receptor), and pro-inflammatory cytokines have created interest in the potential to treat IPF. Brilaroxazine was evaluated in a bleomycin (BLM)-induced rat model of IPF receiving either brilaroxazine 15 mg twice daily for 21 days starting at day 1 (BT) or at day 10 (BI) and demonstrated efficacy with significant improvements in key endpoints in the bleomycin (BLM)-induced rat model of IPF. Currently, the drug is in the Phase I stage of its development for the treatment of IPF.

The Idiopathic Inflammatory Myositis pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Idiopathic Inflammatory Myositis with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Idiopathic Inflammatory Myositis Treatment.
* Idiopathic Inflammatory Myositis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Idiopathic Inflammatory Myositis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Idiopathic Inflammatory Myositis market.

Explore the dynamic world of drug development with our latest Idiopathic Inflammatory Myositis Pipeline Insights report! From early-stage research to late-phase Idiopathic Inflammatory Myositis Clinical Trials, our analysis covers key Idiopathic Inflammatory Myositis Companies, innovative treatment approaches, and the next wave of Emerging Drugs. Don't miss this opportunity to stay informed-download now! @ Idiopathic Inflammatory Myositis Treatment Drugs [https://www.delveinsight.com/sample-request/idiopathic-pulmonary-fibrosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Idiopathic Inflammatory Myositis Companies

FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma Co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd., Ark Biosciences, Ocean Biomedical and others.

Idiopathic Pulmonary Fibrosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Parenteral
* Intravitreal
* Subretinal
* Topical

Idiopathic Inflammatory Myositis Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

The future of medicine is evolving rapidly! Get detailed insights into ongoing Idiopathic Inflammatory Myositis Clinical Trials, major Companies driving innovation, and the most anticipated Emerging Drugs in the pipeline. Stay updated with the latest Idiopathic Inflammatory Myositis Pipeline Insights-download our report for a deep dive into the next generation of therapeutics! @ Idiopathic Inflammatory Myositis Market Drivers and Barriers, and Future Perspectives [https://www.delveinsight.com/sample-request/idiopathic-pulmonary-fibrosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Scope of the Idiopathic Inflammatory Myositis Pipeline Report

* Coverage- Global
* Idiopathic Inflammatory Myositis Companies- FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma Co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd., Ark Biosciences, Ocean Biomedical and others.
* Idiopathic Inflammatory Myositis Therapies- Daxdilimab, Belimumab, Baricitinib, Nipocalimab, Glucocorticoids, Froniglutide and others.
* Idiopathic Inflammatory Myositis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Idiopathic Inflammatory Myositis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which Idiopathic Inflammatory Myositis Emerging Drugs are set to revolutionize treatment landscapes? Which Idiopathic Inflammatory Myositis Companies are leading the way in drug discovery? Find answers in our latest Idiopathic Inflammatory Myositis Pipeline Insights report, featuring in-depth coverage of Clinical Trials, regulatory trends, and upcoming breakthroughs. Download now to stay at the forefront of pharmaceutical innovation!" @ Idiopathic Inflammatory Myositis Emerging Drugs and Companies [https://www.delveinsight.com/sample-request/idiopathic-pulmonary-fibrosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* Idiopathic Pulmonary Fibrosis: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Idiopathic Pulmonary Fibrosis- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Pamrevlumab: FibroGen
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Tipelukast: MediciNova
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* Brilaroxazine: Reviva Pharmaceuticals
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Idiopathic Pulmonary Fibrosis Key Companies
* Idiopathic Pulmonary Fibrosis Key Products
* Idiopathic Pulmonary Fibrosis- Unmet Needs
* Idiopathic Pulmonary Fibrosis- Market Drivers and Barriers
* Idiopathic Pulmonary Fibrosis- Future Perspectives and Conclusion
* Idiopathic Pulmonary Fibrosis Analyst Views
* Idiopathic Pulmonary Fibrosis Key Companies
* Appendix

About Us

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